- The American Stock Transfer & Trust Company, LLC, is suing Sanofi on behalf of Genzyme rights holders. When Sanofi acquired Genzyme and its lead candidate Lemtrada (alemtuzumab) in 2011, the agreement was structured so that Genzyme shareholders would receive milestone payments—assuming Lemtrada was approved by March 31, 2014. The lawsuit alleges that Sanofi intentionally delayed approval of the multiple sclerosis (MS) drug.
- The suit alleges that Sanofi intentionally ignored FDA concerns about clinical trial design.
- When Lemtrada was approved in November 2014, it came with a black box warning and entered a relatively competitive market. At the same time, Sanofi was aggressively marketing Aubagio (teriflunomide), its once-a-day tablet for relapsing MS. Overall, Genzyme rights owners missed out on at least $708 million in milestone payments.
Many merger/acquisition agreements incorporate milestone payments based on achieving certain R&D or approval milestones. The agreement between Sanofi and Genzyme was typical in this fashion. Genzyme came to the table with a lead candidate and Sanofi agreed to usher it through the R&D process, with the goal of achieving certain milestones at specific dates.
The almost eight-month delay between the target approval date for Lemtrada and its actual approval date, as well as Sanofi's decision to privilege Aubagio over Lemtrada (according to the lawsuit), proved costly in many ways. Lemtrada was approved as a disease-modifying therapy with a price tag of $158,000 per two-treatment regimen. The market was ready. As Lemtrada launched, other contenders were entering the market as well. Biogen introduced the oral drug Tecfidera and Novartis unveiled Gilenya. The only downside was that Lemtrada was approved as a third-line therapy.
The major grievance of Genzyme rights holders is a huge lost opportunity for a possible $708 million, and perhaps as much as $3.8 billion, if the allegations are true.
The case, which was just filed this week, is American Stock Transfer & Trust Company LLC v. Sanofi, U.S. District Court, Southern District of New York, No. 1:15-cv-08725.